Dear researchers,
please find information on Clinical Trial Information System - training by the European Medicines Agency. Registration is necessary to participate in the two-day training. This is very relevant and timely for everyone involved and interested in clinical trials. Best regards, Emma
Please find and forward this announcement on a two-part CTIS training event targeted at SME and academia clinical trial sponsors (future CTIS users and their organisations). Day 1: 22 Feb 2021 SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 1 | European Medicines Agency (europa.eu)https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fevents%2Fsme-academia-clinical-trials-information-system-ctis-two-part-training-webinar-day-1&data=04%7C01%7Ckirjaamo%40oulu.fi%7Cec216df5d6c845fc80e108d8bd42f858%7C9f9ce49a51014aa38c750d5935ad6525%7C0%7C0%7C637467442633273805%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=l51QVcEi4JIP2nTYBcCfNWsJcC23297dqffrD9E8D90%3D&reserved=0
Day 2: 4 Mar 2021 SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 2 | European Medicines Agency (europa.eu)https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fevents%2Fsme-academia-clinical-trials-information-system-ctis-two-part-training-webinar-day-2&data=04%7C01%7Ckirjaamo%40oulu.fi%7Cec216df5d6c845fc80e108d8bd42f858%7C9f9ce49a51014aa38c750d5935ad6525%7C0%7C0%7C637467442633273805%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=Ds0SCRPI1yw6Qe15Q1FxRJEjTcAVadLZa%2BydqOtxdbY%3D&reserved=0
The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS will contain the centralised EU portal and database for clinical trials foreseen by the Regulation and will be used by clinical trial sponsors as a single entry point in the EU to obtain approval for clinical trials based on applications and for monitoring clinical trials during their life cycle, including the submission of summary of results.
The system is currently under development and will have collaboration and communication tools, workflow and document management capabilities. It will include a user management tool to enable access for sponsors, Member States and the European Commission via dedicated workspaces. It will also provide general public with access to clinical trials information. CTIS will centralise the submission process for clinical trial applications and the assessment and authorisation by Member States in a single unique platform. It will facilitate day-to-day business processes of Member States and sponsors of clinical trials throughout the lifecycle of a clinical trial harmonising submission and maintenance of trial applications, assessment and supervision of trials and promoting patient safety and transparency.
The Clinical Trials Regulation, Regulation (EU) No 536/2014, will become applicable as CTIS goes live, which is anticipated in December 2021. Once launched, CTIS will be immediately available for authorities and for clinical trial sponsors, while a three-year phased transition period from the current Directive 2001/20/EC to the Regulation will apply.
To facilitate preparedness for use of CTIS users, the European Medicines Agency has developed a training programme to provide future CTIS users with the skills and knowledge to successfully use CTIS into their business. A wide array of comprehensive online training material will be made available gradually in 2021.
For Micro, Small to Medium Enterprises (SMEs) and academia, EMA is organising a targeted webinar to provide training on CTIS and its functionalities. The webinar is divided into two parts (Day 1 and Day 2) and participants are advised to attend both. This two-part event is free of charge.
As per current planning, Day 1 on 22nd February 2021 will present CTIS access management, user management and different roles in CTIS. Day 2 on 4th March 2021 will focus on CTIS functionalities - how to submit and manage a clinical trial application. Transparency of reporting of results will also be presented on Day 2.
The webinar will include presentations by speakers from EMA system experts and presenters from SME and academic institutions, demonstration of the system, and opportunities for questions and answers. The webinar will be recorded and published for future perusal.
Steps to take:
1) Express your initial interest in this two-part CTIS training event aimed at SMEs and academia by completing the expression of interest questions: EUSurvey - Survey (europa.eu)https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fec.europa.eu%2Feusurvey%2Frunner%2FWebinarExpressionOfInterest&data=04%7C01%7Ckirjaamo%40oulu.fi%7Cec216df5d6c845fc80e108d8bd42f858%7C9f9ce49a51014aa38c750d5935ad6525%7C0%7C0%7C637467442633283805%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=fUyvNcpOM1XLkwPwDq7XDhqmr8oeKW7fpm5qS%2Fu4ckA%3D&reserved=0. This initial expression of interest should be made by the 29th January 2021 but is not yet the registration to the training.
2) Based on expressions of interest, you will receive a separate email from EMA including a link to register for the training in the week commencing on 1st February 2021. Registrations will close on 7th February 2021. You will need to register for both dates individually.
Due to the platform used, this two-part CTIS training event is limited to 950 participants. Should more participants express interest to participate, preference will be given to those representing academic institutions and SMEs. The criteria for being classified as an SME can be found herehttps://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fhuman-regulatory%2Foverview%2Fsupporting-smes%2Fapplying-sme-status&data=04%7C01%7Ckirjaamo%40oulu.fi%7Cec216df5d6c845fc80e108d8bd42f858%7C9f9ce49a51014aa38c750d5935ad6525%7C0%7C0%7C637467442633293799%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=Dk%2BTEfXlw93Q6mVs9V2dVC0kyzPgA2PL5vEbhFHM8bo%3D&reserved=0.
For more information on
- this SME/academia event, please contact CT.Sponsortraining@ema.europa.eumailto:CT.Sponsortraining@ema.europa.eu. Replies to this email are directed to CT.Sponsortraining@ema.europa.eumailto:CT.Sponsortraining@ema.europa.eu
- EMA support for SMEs, please see https://www.ema.europa.eu/en/human-regulatory/overview/supporting-smeshttps://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fhuman-regulatory%2Foverview%2Fsupporting-smes&data=04%7C01%7Ckirjaamo%40oulu.fi%7Cec216df5d6c845fc80e108d8bd42f858%7C9f9ce49a51014aa38c750d5935ad6525%7C0%7C0%7C637467442633293799%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=VNoKaOQauhLva39rNYOtfK1V4N7pC0QC%2FYH0dhqyXgU%3D&reserved=0
- EMA engagement with academia, please see https://www.ema.europa.eu/en/partners-networks/academiahttps://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fpartners-networks%2Facademia&data=04%7C01%7Ckirjaamo%40oulu.fi%7Cec216df5d6c845fc80e108d8bd42f858%7C9f9ce49a51014aa38c750d5935ad6525%7C0%7C0%7C637467442633303798%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=3qXChgDJbyAbgu5hLAfYKC9MaLge3BgmZOavPQnq%2Fv0%3D&reserved=0
To stay up to date with developments and plans, please see our CTIS Highlights NewsLetters: https://www.ema.europa.eu/en/news-events/publications/newsletters#clinical-t...https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fnews-events%2Fpublications%2Fnewsletters%23clinical-trials-information-system-(ctis)-highlights-section&data=04%7C01%7Ckirjaamo%40oulu.fi%7Cec216df5d6c845fc80e108d8bd42f858%7C9f9ce49a51014aa38c750d5935ad6525%7C0%7C0%7C637467442633303798%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=nb8V2gq6tZivNDQc91Vq1kDv7zChcynFFTVLloBz6Uw%3D&reserved=0 (to subscribe write to CT.communication@ema.europa.eumailto:CT.communication@ema.europa.eu).
With kind regards from the CTIS Change management team
Fia Westerholm Programme Assurance Manager Clinical Trials Information System (CTIS) programme Clinical Trials and Manufacturing Task Force European Medicines Agency Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands Telephone +31 (0)88 781 8581 Fia.Westerholm@ema.europa.eumailto:Fia.Westerholm@ema.europa.eu | www.ema.europa.euhttps://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen&data=04%7C01%7Ckirjaamo%40oulu.fi%7Cec216df5d6c845fc80e108d8bd42f858%7C9f9ce49a51014aa38c750d5935ad6525%7C0%7C0%7C637467442633313792%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=zDmjj4zm5A8Q8sxlVtlKFTHouM0znEAmoKuqs%2FRShSU%3D&reserved=0 | For directions, see How to find ushttps://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fabout-us%2Fcontact%2Fhow-find-us&data=04%7C01%7Ckirjaamo%40oulu.fi%7Cec216df5d6c845fc80e108d8bd42f858%7C9f9ce49a51014aa38c750d5935ad6525%7C0%7C0%7C637467442633323788%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=HkiK1fyy8PoXWstQdpFl2txHUuQjMe2xyfxrA1KvoG8%3D&reserved=0
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